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Date: 2019-09-03 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 2019

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Gazette Overview

  • 923 samples were declared as of Standard Quality.
  • 28 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious.
  • No samples were declared as Misbranded.
  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for August 2019.
  • A total of 951 samples were tested.

Key Changes - List of Not Standard Quality Items

  • Cefixime Oral Suspension I.P. (Batch No.: MCS-17039) manufactured by M/s. Maxmed Lifesciences Pvt. Ltd. failed due to Assay.
  • Norfloxacin Tablets I.P. 400 mg (Batch No.: NT606) manufactured by M/s. Unicure India Ltd. failed due to Dissolution.
  • Norfloxacin Tablets I.P. 400 mg (NORTEC-400) (Batch No.: NTK-18004) manufactured by M/s. Neutec Healthcare Pvt. Ltd. failed due to Dissolution.
  • PGAB-MB 75 (Pregabalin and Mecobalamin Capsules 75 mg) (Batch No.: WGC1828) manufactured by M/s. West Coast Pharmaceuticals Works Limited failed due to Dissolution for Pregabalin.
  • Levocetirizine tablets I.P. 5mg (Batch No.: 9704418) manufactured by M/s. Karnataka Antibiotics & Pharmaceuticals Limited failed due to Dissolution.
  • Alprazolam tablets I.P. (Batch No.: TAZP-001) manufactured by M/s. Medipol Pharmaceuticals India Pvt. Limited failed due to Dissolution.
  • Eryfast-250 (Erythromycin Stearate Tablets B.P. 250 mg) (Batch No.: MD926) manufactured by M/s. Mihika Pharmaceuticals failed due to Assay.
  • Thyrocure-100 (Thyroxine Tablets I.P. 100 mcg) (Batch No.: THDT611) manufactured by M/s. Unicure India Ltd. failed due to Assay.
  • Eufox-O (Ofloxacin and Ornidazole Tablets) (Batch No.: CJM711031) manufactured by M/s. Celebrity Biopharma Ltd. failed due to Disintegration.
  • Ornizole (Ornidazole Tablets I.P. 500 mg) (Batch No.: T-1710151) manufactured by M/s. Aagya Biotech Pvt. Ltd. failed due to Description.
  • ZEPARA –XT 650 mg (Paracetamol Tablets 650 mg) (Batch No.: 418-955) manufactured by M/s. Zee Laboratories failed due to Dissolution.
  • Ticomox CV (Amoxycillin & Potassium Clavulanate Tablets I.P.) (Batch No.: EBT-18L1588) manufactured by M/s. Edwin Biotech failed due to Assay & Dissolution.
  • MOXCON-CV 625 (Amoxycillin & Potassium Clavulanate Tablets I.P.) (Batch No.: SRDTB-1233) manufactured by M/s. Spas Remedise failed due to Dissolution, Water & Assay of Potassium Clavulanate.
  • Framycetin Skin Cream (Soframycin Skin Cream) (Batch No.: N8080) manufactured by M/s. Sanofi India Limited failed due to Assay.
  • Monozin 50 (Cefpodoxime Proxetil Oral Suspension I.P.) (Batch No.: SRDS-1031 ) manufactured by M/s. Spas Remedies failed due to Assay & “Stability of Cefpodoxime”.
  • Clopidogrel & Aspirin Tablets (Batch No.: T8202) manufactured by M/s. Bharat Parenterals Ltd. failed Free Salicylic Acid Test.
  • Frusemide Injection I.P. 2 ml (Batch No.: AI18064) manufactured by M/s. Alves Healthcare Pvt. Ltd. failed Extractable Volume.
  • Dermacur Cream 20g (Clobetasol Propionate Cream) (Batch No.: E19009) manufactured by M/s. Curis Lifesciences Pvt. Ltd. failed due to Assay.
  • FLI Drops Eye Drops 5 ml (Fluorometholone Acetate Ophthalmic Suspension 0.1% w/v) (Batch No.: FLD904021) manufactured by M/s. Senses Phamaceuticals Ltd. failed due to Assay.
  • Dulcoflex (Biscodyl Tablets I.P. 5 mg) (Batch No.: DLA18146) manufactured by M/s. Recipharm Pharmaservices Pvt. Ltd. failed due to Disintegration.
  • Ciprofloxcin Tablets I.P. 500mg (Batch No.: RCTW-06) manufactured by M/s. Nestor Pharmaceuticals Limited failed due to Dissolution.
  • Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.) (Batch No.: I-17225) manufactured by M/s. Jackson Laboratories Pvt. Ltd. failed due to Assay of Potassium Clavulanate.
  • Abiraterone Acetate (Batch No.: 20180303) manufactured by M/s. Shijiazhuang Dingmin Pharmaceuticals Sciences Co. Ltd. failed due to Water Content & Assay.
  • Calcium-Vitamins Tonic (CALCINOL SYRUP) (Batch No.: T18016) manufactured by M/s. Raptakos, Brett & Co. Ltd. failed due to Assay of Cyanocobalamin.
  • (RANITIDINE INJECTION IP) (Batch No.: HLI849K) manufactured by M/s. Himalaya Meditek Pvt. Ltd. failed due to Particulate Matter.
  • Allopurinol Tablets IP 300 mg (AURINOL-300 TABLETS) (Batch No.: AT/5515) manufactured by M/s. Apple Biotech failed due to Assay and Dissolution.
  • Lactic Acid Bacillus Capsules (VIZYLAC CAPSULES) (Batch No.: G2AD219010) manufactured by M/s. Uni Medicolabs failed due to Uniformity of filled weight.
  • Gabapentin 400 mg and Nortriptyline 10 mg Tablets (DOLENEURON NT TABLETS ) (Batch No.: DNT1099D) manufactured by M/s. Pulse Pharmaceuticals Pvt. Ltd. failed due to Assay of Nortriptyline.

Impact Analysis

Impact on Manufacturers

  • Manufacturers may need to review their supply chain and manufacturing processes to ensure the quality of raw materials and finished products.

Impact on Consumers

  • Consumers should consult healthcare professionals if they have concerns about the quality of their medications.

Impact on Regulatory Agencies

  • This notification highlights the need for continuous monitoring and improvement of drug quality control systems.

Suggested Action Items

  • Provide training to employees on quality control and manufacturing best practices.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory CDL: Central Drugs Laboratory Drugs and Cosmetics Act: The primary legislation governing the quality, safety, and efficacy of drugs and cosmetics in India. (Implied)
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of August 2019 Total number of samples tested 951 Total number of samples declared as of Standard Quality 923 Total number of samples declared as Not of Standard Quality 28 Total number of samples declared as Spurious Nil Total number of samples declared as Misbranded Nil S. Name of Batch No./Date of Reason for failure Drawn By From N. Drugs/medical Manufacture/Date of device/cosmetics Expiry/Manufactured By 1. Cefixime Oral B. No.: MCS-17039, Assay Drug Control RDTL, Suspension I.P. Mfg dt: 09/2017, Department, Guwahati Exp dt: 08/2019, Arunachal Mfd by: M/s. Maxmed Pradesh Lifesciences Pvt. Ltd. Plot No. 54, Sector IIDC SIDCUL Rudrapur, Uttarakhand. 2. Norfloxacin Tablets B. No.: NT606, Dissolution Drug Control RDTL, I.P. 400 mg Mfg dt: 02/2019, Department, Guwahati Exp dt: 01/2021, Assam Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector-3, Noida, Gautam Budh Nagar, Uttar Pradesh-201301. 3. Norfloxacin Tablets B. No.: NTK-18004, Dissolution Drug Control RDTL, I.P. 400 mg Mfg dt: 03/2019, Department, Guwahati Exp dt: 02/2022, (NORTEC-400) Meghalaya Mfd by: M/s. Neutec Healthcare Pvt. Ltd. E- 698, DSIIDC Narela, Industrial Area Delhi- 110040. 4. PGAB-MB 75 B. No.: WGC1828, Dissolution for CDSCO, CDTL, (Pregabalin and Mfg dt: 06/2018, Pregabalin Ahmedabad Mumbai Exp dt: 05/2021, Mecobalamin Mfd by: M/s. Capsules 75 mg) West Coast Pharmaceuticals Works Limited, FP-17 & 16/5 Meldi Mata Temple Near Gota railway Station Crossing, Gota, Ahmedabad – 382481, Gujarat.5. Levocetirizine B. No.: 9704418, Dissolution CDSCO, CDTL, tablets I.P. 5mg Mfg dt: 12/2018, West Zone, Mumbai Exp dt: 11/2021, Mumbai Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited )A Govt. of India Enterprise), Plot No. 14, II Phase, Peenya, Bengaluru – 560058. 6. Alprazolam tablets B. No.: TAZP-001, Dissolution CDSCO, CDTL, I.P. Mfg dt: 11/2018, West Zone, Mumbai Exp dt: 10/2020, Mumbai Mfd by: M/s. Medipol Pharmaceuticals India Pvt. Limited, 1199/3, Bhud, Baddi, distt. Solan. Himachal Pradesh. 7. Eryfast-250 B. No.: MD926, Assay CDSCO, CDTL, (Erythromycin Mfg dt: 04/2019, West Zone, Mumbai Exp dt: 02/2022, Stearate Tablets Mumbai Mfd by: M/s. Mihika B.P. 250 mg) Pharmaceuticals, 506, Parmeshwari Centre, 18, Dalmia estate, Mulund (W), Mumbai – 400 080. 8. Thyrocure-100 B. No.: THDT611, Assay CDSCO, East CDL, Kolkata (Thyroxine Tablets Mfg dt: 12/2018, Zone, Kolkata Exp dt: 05/2020, I.P. 100 mcg) Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida – 201 301, Distt. Gautam Budh Nagar (Uttar Pradesh). 9. Eufox-O (Ofloxacin B. No.: CJM711031, Disintegration CDSCO, East CDL, Kolkata and Ornidazole Mfg dt: 11/2017, Zone, Kolkata Exp dt: 10/2020, Tablets) Mfd by: M/s. Celebrity Biopharma Ltd., Vill: Panga Hill Top Estate, Via-Jharmajri, Barotiwala, Distt. Solan, Himachal Pradesh. 10. Ornizole B. No.: T-1710151, Description CDSCO, East CDL, Kolkata (Ornidazole Mfg dt: 10/2017, Zone, Kolkata Exp dt: 09/2019, Tablets I.P. 500 Mfd by: M/s. Aagya mg) Biotech Pvt. Ltd., 1.5 KM, Manglour- Saharanpur Road, Manglour-247656, Roorkee, Distt. Haridwar, (Uttarakhand). 11. ZEPARA –XT 650 B. No.: 418-955, Dissolution CDSCO, East CDL, Kolkata mg (Paracetamol Mfg dt: 10/2018,Tablets 650 mg) Exp dt: 09/2020, Zone, Kolkata Mfd by: M/s. Zee Laboratories, Industrial Area, Paonta Sahib- 173025. (Himachal Pradesh). 12. Ticomox CV B. No.: EBT-18L1588, Assay & CDSCO, CDL, Kolkata (Amoxycillin & Mfg dt: 12/2018, Dissolution Baddi Exp dt: 02/2020, Potassium Mfd by: M/s. Edwin Clavulanate Biotech, Plot No. 184, Tablets I.P.) Indl. Area, Phase IX, SAS, 160059 (Punjab). 13. MOXCON-CV 625 B. No.: SRDTB-1233, Dissolution, Water CDSCO, CDL, Kolkata (Amoxycillin & Mfg dt: 06/2019, & Assay of Baddi Exp dt: 11/2020, Potassium Potassium Mfd by: M/s. Spas Clavulanate Clavulanate Remedise, Vill. Bersan, Tablets I.P.) P.O. - Lodhi Majra, Teh. Baddi, Distt. Solan – 173 205 (Himachal Pradesh). 14. Framycetin Skin B. No.: N8080, Assay CDSCO, CDL, Kolkata Cream (Soframycin Mfg dt: 04/2018, Baddi Exp dt: 09/2020, Skin Cream) Mfd by: M/s. Sanofi India Limited, Plot No. C-1, Madkaim Ind. Estate, Ponda, Goa – 403 404. 15. Monozin 50 B. No.: SRDS-1031 , Assay & “Stability CDSCO, CDL, Kolkata (Cefpodoxime Mfg dt: 03/2019, of Cefpodoxime” Baddi Exp dt: 02/2021, Proxetil Oral Mfd by: M/s. Spas Suspension I.P.) Remedies, Vill. Bersan, P.O. Lodhi Majra, Teh. Baddi, Distt. Solan – 173 205. (Himachal Pradesh). 16. Clopidogrel & B. No.: T8202, Free Salicylic Acid CDSCO, CDL, Kolkata Aspirin Tablets Mfg dt: 07/2018, Test Ahmedabad Exp dt: 06/2020, Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391 520,Gujrat. 17. Frusemide B. No.: AI18064, Extractable CDSCO, CDL, Kolkata Injection I.P. 2 ml Mfg dt: 07/2018, Volume Ahmedabad Exp dt: 06/2020, Mfd by: M/s. Alves Healthcare Pvt. Ltd., Nangal Uperia, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh – 174 101. 18. Dermacur Cream B. No.: E19009, Assay CDSCO, CDL, Kolkata 20g (Clobetasol Mfg dt: 01/2019, AhmedabadPropionate Cream) Exp dt: 36 months from date of mfg, Mfd by: M/s. Curis Lifesciences Pvt. Ltd., PF-23, Sanand GIDC - II, Sanand, Ahmedabad – 382110. 19. FLI Drops Eye B. No.: FLD904021, Assay CDSCO, CDL, Kolkata Drops 5 ml Mfg dt: 04/2019, Bangalore Exp dt: 03/2021, (Fluorometholone Mfd by: M/s. Senses Acetate Phamaceuticals Ltd., No. Ophthalmic 77, 3rd Road, Suspension 0.1% Bommasandra Industrial w/v) Area, Bommasandra 4th Phase, Bangalore – 560 099. 20. Dulcoflex (Biscodyl B. No.: DLA18146, Disintegration CDSCO, CDL, Kolkata Tablets I.P. 5 mg) Mfg dt: 12/2018, Bangalore Exp dt: 11/2021, Mfd by: M/s. Recipharm Pharmaservices Pvt. Ltd., Khatha No. 845/713 & 1108/970/1, 34th KM, Tumkur Road, T- Begur, Nelamangala, Bangalore, Rural – 562123. 21. Ciprofloxcin B. No.: RCTW-06, Dissolution CDSCO, CDL, Kolkata Tablets I.P. 500mg Mfg dt: 01/2019, North Zone, Exp dt: 12/2021, Ghaziabad Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Westrn Extension Area Faridabad – 121001, India. 22. Climox 1.2g B. No.: I-17225, Assay of CDSCO, CDL, Kolkata (Amoxycillin & Mfg dt: 06/2018, Potassium Sub-Zone, Exp dt: 05/2020, Potassium Clavulanate Goa Mfd by: M/s. Jackson Clavulanate Laboratories Pvt. Ltd., Injection I.P.) 22-24, Majitha Road, Bye Pass, Amritsar 143001 (India) Punjab. 23. Abiraterone B. No.: 20180303, Water Content & CDSCO, CDTL, Acetate Mfg dt: 03/2018, Assay Zone Chennai Exp dt: 03/2020, Mfd by: M/s. Shijiazhuang Dingmin Pharmaceuticals Sciences Co. Ltd., No. 41 Zhaiyng South Street, Shijiazhuang, Hebei, China24. Calcium-Vitamins B. No.: T18016, Assay of CDSCO, RDTL, Tonic (CALCINOL Mfg dt: 07/2018, Cyanocobalamin North-Zone Chandigarh Exp dt: 12/2019, SYRUP) Ghaziabad, Mfd by: M/s. Raptakos, (UP). Brett & Co. Ltd. 1st Pokhran Road, Thane- 400606. 25. (RANITIDINE B. No.: HLI849K, Particulate Matter CDSCO, RDTL, INJECTION IP) Mfg dt: 10/2018, Ghaziabad Chandigarh Exp dt: 09/2020, (UP). Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36 Pharmacity Selaqui, Industrial Area Dehradun-248197 (Uttarakhand). 26. Allopurinol Tablets B. No.: AT/5515, Assay and CDSCO, RDTL, IP 300 mg Mfg dt: 11/2018, Dissolution Sub-Zone- Chandigarh Exp dt: 10/2020, (AURINOL-300 Baddi, H.P. Mfd by: M/s. Apple TABLETS) Biotech Vill.Deep Nagar, Teh Payal, Ludhiana- 141421 (Punjab) India. 27. Lactic Acid Bacillus B. No.: G2AD219010, Uniformity of filled CDSCO, RDTL, Capsules Mfg dt: 02/2019, weight North-Zone, Chandigarh Exp dt: 07/2020, (VIZYLAC Ghaziabad, Mfd by: M/s. Uni CAPSULES) UP. Medicolabs Plot No. 25 & 26, Pharma City, Selaqui, Dehradun (Uttrakhand). 28. Gabapentin 400 B. No.: DNT1099D, Assay of CDSCO, RDTL, mg and Mfg dt: 04/2019, Nortriptyline North-Zone, Chandigarh Exp dt: 01/2021, Nortriptyline 10 mg Ghaziabad, Mfd by: M/s. Pulse Tablets UP. Pharmaceuticals Pvt. Ltd. (DOLENEURON Khasra No:- 400,407 and NT TABLETS ) 409, Karondi, Roorkee, Uttarakhand-247667.

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